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Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis

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ClinicalTrials.gov Identifier: NCT03504657
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University

Brief Summary:
Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. However, in-stent restenosis rate have been reported as high as more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.

Condition or disease Intervention/treatment Phase
Vertebral Artery Stenosis Device: Drug-coated balloon angioplasty Device: stenting angioplasty Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: Drug-coated balloon angioplasty Device: Drug-coated balloon angioplasty
Angioplasty with a drug-coated angioplasty

Active Comparator: stenting angioplasty Device: stenting angioplasty
Angioplasty with a stenting




Primary Outcome Measures :
  1. Restenosis [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The composite of vascular death, myocardial infarction, or any stroke [ Time Frame: within 30 days after the start of treatment ]
  2. The composite of vascular death, myocardial infarction, or any stroke [ Time Frame: within 12 months after the start of treatment ]
  3. Death resulting from any cause [ Time Frame: 12 months ]
  4. Stroke in the supply territory of the symptomatic vertebral artery [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Serious adverse events [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Patients presenting with posterior circulation transient ischemic attack or nondisabling stroke in the previous 6 months
  • Vertebral artery origin stenosis resulting from presumed atheromatous disease with stenosis ≥50%
  • Lesion length of the stenosis >5mm.
  • Angioplasty can be performed within two weeks after randomization
  • Female subjects of childbearing potential have a negative pregnancy test.
  • Signed informed consent prior to entering study

Exclusion Criteria:

  • Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation)
  • Life expectancy shorter than 2 years
  • Vertebral artery stenosis caused by dissection
  • Vertebral stenting felt to be technically impracticable
  • Previous stenting in randomized artery
  • Pre-morbid modified Rankin scale score of greater than 3
  • Currently participating or previously participated in any investigational drug or device study within 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504657


Contacts
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Contact: Chuanjie Wu, MD 008618911366882 wuchuanjie8557@163.com

Locations
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China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450000
Contact: Yajun Lian, MD    008613838367143    lianyajun369@yahoo.com   
China
Nanyang City Center Hospital Recruiting
Nanyang, China
Contact: Changming Wen, MD         
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University

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Responsible Party: Chuanjie Wu, MD, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT03504657     History of Changes
Other Study ID Numbers: FAHZU-2018-006
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University:
Vertebral Artery Stenosis
Drug-coated balloon angioplasty
Stenting

Additional relevant MeSH terms:
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Constriction, Pathologic
Vertebrobasilar Insufficiency
Pathological Conditions, Anatomical
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases